What happens when packaging passes through the quality challenge

Prasad Balan lyer, director, SIES School of Packaging moderated the session which comprised of Shivkumar Vishwanathan, vice president marketing, GVS Cibatech; Ravindran M, packaging R&D, General Mills India; Bhanupriya Munta, assistant manager, Shalina Laboratories; and Suresh Kunjan, head laboratory-package testing, SIES School of Packaging.

Quality has many dimensions. And, comparing testing values and field results is like comparing apples and oranges. With panellists representing both sides of the ecosystem: consumers and testing, the 75 minutes provided an insight into the qualitative aspect of packaging.

Prasad Balan Iyer (PBI): Representing the user industry, how important is packaging quality in the complete packaging design and development process? Where do you place packaging quality in the scheme of things?

Ravindran M (RM): Quality is a critical parameter. It needs to be incorporated from day-one of the development cycle. To achieve this, one must be a packaging technologist first, and then become a packaging manager or project-manager.

PBI: Why so?

RM: It ensures the product is understood, and defines associated parameters including quality, design, dimensional, performance aspects which further comprises target values, tolerance limits. It plays a critical role in the design and development stage. With thorough knowledge of the development cycle, one can ensure effective communication with suppliers and vendors. Their learnings include understanding the right kind of material, its performance parameters which are gradually specification systems and documents for qualification. I feel quality is an important parameter which must be mastered right from the design stage.

PBI: Suresh Kunjan, as the head of package testing, how do you see quality testing and evaluation as an important parameter in any packaging industry? How significant this aspect is up to the specification criterion in the development process, especially for freshers?

Suresh Kunjan (SK): Quality testing is an important topic from the students point of view. The key point is specifications. In addition to Ravindran’s point that quality must be inculcated since the design phase, it is crucial to lay down a document of specifications. From the laboratory perspective, it acts as a reference for tested values to the actual required value, with minimal tolerance.

PBI: What is the advantage?

SK: In the design phase, the specification is drafted. This sets forth the medium for development. If the drafting is not done, what is the basis on which we are going to move ahead? So, the document becomes an important parameter for evaluation. And so, accepting or rejecting an order, is not a personal whim, rather the document speaks. Be it evaluation or argument, the inception concerns specifications. For the quality control department, this document must be regarded as the Bible.

PBI: Bhanupriya, in the stringent pharma industry, how do you see material evaluation or testing parameters or quality control? How do you view it differently compared to other companies from the FMCG sector? How do you think the pharma industry tackles it differently?

Bhanupriya Munta (BM): Quality is not restricted to pharma. It applies to every industry. However, what sets pharma apart from the rest is the shelf life of products. The former desires shelf life to keep up till the last drop or tablet has been used by the customer.

PBI: Would you like to respond to Ravindran’s point about packaging materials ...

BM: Yes, elaborating on Ravindran’s speech, packaging materials specifications or packaging technologists must allot 60% weightage while designing the product. As you know, there are two components - quality by design and quality by conformance. As a technologist, one should be aware of the packaging materials that are available in the industry, and what market it is aimed at. 

Also, it is not feasible to rely on a single vendor. So, we require a combination or a discussion with the vendors regarding our needs. My suggestion is whenever we are doing stability study for a new product, never rely only on one packing component. Instead, try two-three options because every component will have its own specification plus its own qualities. Irrespective of the material selected, it must be compatible to run on the machine, and not interact with the product.

PBI: What about non primary materials?

BM: Pharma is not only about the primary packing material but also the secondary, intermediate and shipper are crucial. This is  because it has to reach the retailer and the customer in perfect condition. We must be vigilant about every component in the value chain.

PBI: I feel packaging technologists need to be material scientists. I would like to ask Sukumar Vishwanathan, who is from a niche area of testing. Do you think extractables and leachables for the pharma industry are understood by people? If you can explain the concept, and highlight the significance… 

Shivkumar Vishwanathan (SV): Firstly, I would like to add that a packaging technologist also needs to be a regulatory expert. In pharma, the expectations are increasing and it's onerous to keep up with the regulations. As a packaging producer or a converter, I need to know what is the product inside my packaging material. Ultimately, the packaging material should pass the risk assessment, failing which your customer who is actually manufacturing the drug product will not get the approval. The customer can incur a huge loss. Once an application is rejected, it can take six months to a year to get the license.

PBI: What is the solution?

SV: There must be thorough research about what goes inside the packaging material through extraction studies. After which one must do the stability studies to test its yield. These are extensive, time consuming studies so one cannot afford troubleshooting later on in the cycle. So, right at the product development stage, pharmaceutical companies should recognise the role a packaging person plays in the process.

PBI: If we talk about the different stakeholders who are involved in packaging, how frequently do you interact with them, and how much do you have to educate them or create awareness concerning the importance of a particular test?

RM: It is a must-have for all the professionals in the industry across all segments from the user, converter, vendor, supply, raw materials, ingredient supplier and eCommerce and retailers. Education about the quality parameters, anti-control measures and compliances. There must be a refresher session biannually or annually if possible or tie-up sessions with institutions like SIES School of Packaging (SOP) or Indian Institute of Packaging (IIP). This is how the industry can adhere to standards, in terms of performance and development parameters. Also, there are other regulatory and compliance criterions for the food industry.

PBI: There are multiple times about getting inquiries to test a material or evaluate a state of a material, or to do a compatibility study of exposure to a certain temperature and humidity. Do you think there is awareness of the scope of the test, or is it merely just considered a requisite?

SK: Understanding standards is essential to evaluate and communicate, when it comes to testing a material. For a material to achieve optimum result, if there arises a need to customise the standard, one needs to do so with minimal tolerance. The customisation of the test can be done, given that standard operating procedure (SOP) is constant.

RM: You need to understand what is the purpose, assess the root cause of the standards and the methods. There must be awareness for technical purpose, commercial purpose, and to have a realistic understanding of what could be the outcome and how to use the best results in terms to set some quality parameters. For this you need to have a holistic educational approach and recruitment system.

PBI: In this regard, if one considers a film or a laminate. Initially it's an open structure and the filament laminate, you have test results of the de-laminated structure, how do you correlate that to a sponge structure during its shelf life?

BM: We need to first understand the manufacturing process and vendor. Basically, analysing your product, analysing your consignments, analysing the behaviour of the packing material is important.

PBI: Please explain.

BM: The test for oxygen transmission rate (OTR) and water vapour transmission rate (WVTR) on laminates is done in an open form. And, the product’s end format is a sachet or tube. So, the challenge is to correlate and whether the packing material is suitable to sustain till the estimated shelf life.

SV: I have another dimension to this discussion. Let’s assume all work and specifications are fixed, but the equation changes when it comes down to cost factor. The purchase takes independent decisions, and affects the product quality. So, there must be awareness regarding organisational setting specifications as to why implementation is critical.

PBI: Actually, the purchase has impacted without analysing the adverse effect it will have either during the transportation or for its actual function. Suresh Kunjan, can you please elucidate on this aspect?

SK: Let’s say you have a 80 micron with 5% tolerance. It is considered the minus side, which is a problem. As Bhanupriya pointed out, the shelf life does not go as written. The solution is menial tolerance, and incorporating from the design stage. This brings us back to our initial point for the specification to be drafted properly.

PBI: What about testing fresh laminates?

SK: About testing on fresh laminates received from the vendors, in the pouch form the calculation does not match. One of the tests is Gelbo on the laminates, followed by WVTR and OTR. The former twists the laminate and induces creases on it, this reduces the shelf life.

RM: A quick note on rigid plastics. We set interference dimensions and tolerance for a snap fit cap on a PET bottle. But there arose an issue of gap between thereby causing leakage. In reducing the tolerance, the supplier efficiency in production went high with extra labour or wastage percentage increasing. So, the right kind of techno-commercial balance has to be made when you're setting your quality control parameter. In this case, awareness of material behaviour, the production lines from where the material is getting converted plays an important role in making your verification document. This is a practical approach which ensures optimum performance from your packaging so that it can perform its functions in the marketplace.

PBI: Shivkumar Vishwanathan, please enlighten us with a case study where you need to marry the material knowledge and process knowledge, and come up with testing parameters to correlate with the market requirement.

SV: Besides quality, safety is another crucial factor to consider. I would like to share a case where a medical device developed by Philips failed to fulfil standards. Its material was found to release carcinogenic gases. The US FDA reported this and fined the brand with a penalty of USD 6 bn. So, in pharmaceuticals, it is a requisite to prove safety compatibility for regulators to approve the device launch in the market.

PBI: To understand the process of how the material is going to interact with the product, we need to understand the product sensitivity. How frequently do you think people correlate field data with actual results? Or is there a gap in understanding gap correlation in actual field study visits or field reports?

SK: In practice, when the material is loaded onto a truck. A thought strikes to accommodate/load more goods at the top. The testing has been done considering the stack height, say seven in the warehouse. But upon overloading, there is ignorance of the fact that the lowest most boxes take the beating. Thereby, the field trials do not correlate with testing value.

RM: Lastly, I wish to add that the material must be understood from the chemistry point of view, the physics point of view and the mathematical point. The commercial aspect will pass only when the scientific parameters are adhered to.